Safety and Efficacy of Ex Vivo Corneal Cross-Linking of Donor Corneal Tissue Used For a Penetrating Keratoplasty
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Keratoconus
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: This is an open-label, single-center, pilot clinical trial to assess the safety and efficacy of ex vivo corneal crosslinking of donor corneal tissue used for penetrating keratoplasty in patients with keratoconus. The study will include 10 participants; these individuals will receive the previously crosslinked corneal tissue for their corneal transplant. Participants will receive close follow-up for up to two years for evaluation of safety and efficacy.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 50 years
- Gender
- Both males and females
Description
In this study, ten patients with keratoconus who will undergo their first corneal transplant surgery in the study eye will be included. When a screened participant meets the inclusion and exclusion criteria to be enrolled in the study, the investigator will request a cornea from the central eye bank...
In this study, ten patients with keratoconus who will undergo their first corneal transplant surgery in the study eye will be included. When a screened participant meets the inclusion and exclusion criteria to be enrolled in the study, the investigator will request a cornea from the central eye bank. The eye bank will then prepare and crosslink the corneal tissue with riboflavin (Vitamin B2) and ultraviolet A (UVA) light. This prepared corneal tissue will be used for the corneal transplant of the patients. Subjects will be followed up post-operatively by the site investigators with a follow-up period of 24 months and standard of care follow-up every six months for up to 3 years or until study closure. The investigators will monitor for systemic and ocular adverse events at all follow-up visits.
Tracking Information
- NCT #
- NCT04584125
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Joseph B Ciolino Massachusetts Eye and Ear
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